Job description
- Regulatory assessments to ensure product compliance and support new products
- Execute plans, complete tasks according to priorities set by Manager, align work with business goals, and align actions with agreed strategies.
- Excellent communication skills and ability to effectively present scientific data both in writing and verbally to cross functional teams.
Major Responsibilities:
- Review and maintain regulatory documents and files (including product label, promotional materials, manufacturing change requests, and registration packages); record product filings, approvals, and registration activities.
- Support submission/filing projects and implement strategies to address issues throughout the filing process.
- Coordinating implementation of regulatory policy in compliance with company standards and policies
- Support in developing proactive regulatory strategies and risk assessments to protect and expand product access within market
Accountability/Scope
- Responsible for tracking and timely completion of registration and/ or licensing activities assigned.
- Developing and reviewing innovation and novel brands / business pipeline regulatory strategies in collaboration with Manager
- Lead the approval process (Regulatory Affairs) pertinent to the procurement of raw materials.
- Lead the approval process for all Labels
- Plant (Manufacturing Unit) related licenses and approvals.
- Completion of registration packages, completion of document review/approval, and product label material review as per project time-line.
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